Medical writer

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (eg, Protocols and Statistical Analysis Plans), as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

• The Clinical Documentation Specialist facilitates improvement in the overall quality, completeness and accuracy of medical records documentation.
• Reviews and recommends opportunities for documentation improvement through extensive record review.
• Obtains appropriate clinical documentation through extensive interaction with physicians, patient care providers and the coding team to ensure the clinical documentation reflects the level of service rendered to the patient is complete and accurate.
• Educates members of the patient care team regarding documentation guidelines on an ongoing basis.
• Demonstrates knowledge and skills necessary to assign an accurate severity of illness.

Nurse Clinical Documentation Specialist

• Develop regulatory documents for submission to regulatory agencies globally
• Manage medical writing projects, including developing timelines
• Participate in cross-functional meetings to provide input regarding medical writing deliverables
• Review other documents associated with the assigned project(s)

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

• Develop scientific copy for various deliverables on assigned brands and products
• Work independently and collaboratively with medical writers and directors to develop scientifically accurate copy
• Understand medical strategy and content objectives for assigned projects and accounts
• Proactively check-in with senior medical leads on project deliverables and raise questions as needed
• Review current literature for assigned therapeutics areas, including competitor products
• Understand and adhere to AMA/client style guidelines as directed
• Ensure references are accurate and research additional references or source materials as necessary
• Annotate and highlight references for medical review
• Manage workflow for assigned projects and meet associated deadlines
• Communicate with clients and/or KOLs to present scientific projects for review and feedback
• Incorporate and discuss edits requested by clients, KOLs, and/or internal reviewers
• Attend and participate in kickoff, status, and other job-related meetings
• Collaborate with creative and illustrative team members to make scientific data visually compelling and scientifically accurate
• Provide medical guidance to team by maintaining up to date scientific knowledge for assigned brands and products

Medical Writer

• Lead end-to-end development of scientific publications, including manuscripts, abstracts, posters, plain language summaries, and congress materials
• Translate publication plans into executable content; identify scientific storylines and recommend approaches to clients and authors
• Ensure compliance with ICMJE, GPP 2022, and journal-specific requirements; serve as a guidelines resource for the wider team
• Translate complex clinical and scientific data into clear, concise, and accurate content for expert audiences — and for lay audiences where required
• Conduct literature reviews and contribute to data interpretation that informs both content and strategy
• Maintain consistency in messaging, tone, and scientific accuracy across deliverables and across an account
• Own author and steering committee engagement, including kickoff meetings, content reviews, and consensus-building across multi-author teams
• Partner with account, strategy, and scientific leads to shape content direction; contribute to scope development and new business work as needed
• Mentor junior writers through structured review, coaching, and onboarding; act as a quality checkpoint on team deliverables
• Build and maintain therapy area expertise; act as a scientific point of contact for an assigned franchise or account
• Apply AI-enabled writing, literature review, and analytics tools thoughtfully and in line with Real Chemistry's responsible-use standards
• Deliver projects on time and to a high standard, proactively managing workload, surfacing risks early, and adapting to changing priorities without compromising quality

Senior Medical Writer – Publications

• Educates all internal customers, including physicians, nurses and other ancillary personnel, on clinical documentation opportunities, coding and reimbursement issues, as well as performance improvement methodologies
• Creates job aids and queries in support of training initiatives
• Ensures the accuracy and completeness of clinical documentation used for measuring and reporting physician and hospital outcomes as well as appropriateness of treatment setting
• Conducts follow-up reviews of clinical documentation to ensure points of clarification have been recorded in the patient's chart
• Reviews clinical issues with coding staff, nurses and other healthcare professionals as appropriate to ensure appropriate inpatient technical diagnosis and procedural coding
• Discusses cases with physicians/provides, including periodic meetings, rounding and/or attending medical staff meetings
• Inputs activities from concurrent reviews into CDI solution and ensures consistency of data captured
• Serves as a member of the facility CDI Team and Documentation Improvement Work Group, providing input relative to documentation improvement processes and resources, and updates corporate HIM on facility coding/documentation improvement efforts
• Performs other relevant duties as assigned

Clinical Documentation Specialist

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Clinical Documentation Integrity Specialist

• Able to write and coordinate basic and complex documents
• Leads in a team environment and matrix
• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents
• Leading cross-functional document planning and review meetings
• Interacting with cross-functional colleagues on document content
• Responsible for establishing document timelines and strategies
• Completing all time reporting, training, metrics database, and project tracking updates as required

Medical Writer III

• Writing or coordinating clinical and regulatory documents such as, but not limited to, CSRs, IBs, protocols, summary documents, RMPs, regulatory responses, and briefing documents.
• Leading cross-functional (eg, with clinical team) document planning and review meetings.
• Interacting with cross-functional colleagues on document content and champions MW processes and best practices.
• Responsible for establishing document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
• Completing all time reporting, training, metrics database, and project tracking updates as required in relevant company systems.
• Able to function as a lead writer on most compounds (or submissions, indications, or disease areas) under supervision.
• Is primary point of contact for medical writing activities for the cross-functional team (eg, clinical).
• Coaching or mentoring more junior staff on document planning, processes, and content.
• Provides peer review as needed.
• Actively participating in or leads process working groups.

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Senior Principal Medical Writer – Regulatory Submission Docs, ISE/ISS/Clinical Overview, Oncology Preferred

Nurse Clinical Documentation Specialist

Senior Principal Medical Writer – Regulatory Submission Docs, Oncology Preferred

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Clinical Documentation Specialist

Clinical Documentation Integrity Specialist

Medical Writer III

Medical Writer III